The following data is part of a premarket notification filed by Home Care Technology Co., Ltd. with the FDA for Home Care Vareious Models Of Powered Muscle Stimulator, Ht-311, Ht-311n, Ht-312.
Device ID | K022998 |
510k Number | K022998 |
Device Name: | HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312 |
Classification | Stimulator, Muscle, Powered |
Applicant | HOME CARE TECHNOLOGY CO., LTD. 2064 TAMARIN DR. Columbus, OH 43235 |
Contact | Shu-chen Cheng |
Correspondent | Shu-chen Cheng HOME CARE TECHNOLOGY CO., LTD. 2064 TAMARIN DR. Columbus, OH 43235 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-09 |
Decision Date | 2003-05-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04719873683208 | K022998 | 000 |